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New Data At ERA-EDTA Show Mimpara(R) (Cinacalcet) Improves Management Of Secondary Hyperparathyroidism In Daily Clinical Practice

July 18, 2017

Amgen (Europe) GmbH announced results from the Evaluation of the Clinical Use of Mimpara in Haemodialysis and Peritoneal Dialysis Patients, an Observational Study (ECHO) at the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) congress. Data show that a higher percentage of dialysis patients with secondary hyperparathyroidism (SHPT) achieved and maintained National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQITM) targets with Mimpara® (cinacalcet), compared to their previous treatment (vitamin D sterols and phosphate binders). In addition, data also show that Mimpara effectively controls SHPT regardless of whether patients were receiving concomitant vitamin D.

"The achievement and maintenance of KDOQI targets is desirable for achieving optimal SHPT patient management. For the first time, these new final data demonstrate cinacalcet's effectiveness in daily clinical practice, confirming that improvements seen with cinacalcet in randomised clinical trials can be reproduced in the clinic," said Doctor Neil Ashman, consultant nephrologist and honorary senior lecturer, Renal Unit, Barts and the London NHS Trust, London, UK.

Results from this pan-European observational study demonstrate that a higher percentage of SHPT patients (n=1865) achieved and maintained KDOQI targets for all four parameters - parathyroid hormone (iPTH), phosphorus (P), calcium (Ca) and calcium phosphorus product (Ca x P) - for up to 12 months following initiation of Mimpara, compared to their previous treatment (standard care: vitamin D sterols and phosphate binders). KDOQI targets include iPTH 150-300 pg/ml, 3.5-5.5 mg/dl, Ca 8.4-9.5 mg/dl, Ca x P About SHPT

Secondary hyperparathyroidism (SHPT) is a metabolic disorder that develops in chronic kidney disease (CKD) patients on dialysis and results in increased secretion of parathyroid hormone (PTH), which may lead to bone disease, bone pain and fractures, cardiovascular and soft tissue calcification and parathyroid hyperplasia.

Patients develop SHPT as their kidneys fail because their ability to excrete phosphorus and produce active vitamin D diminishes, leading to a fall in blood calcium levels. Additionally, a low level of calcium results in stimulating the parathyroid gland to secrete more PTH in an attempt to normalise blood levels of calcium. Over time, continuous PTH secretion leads to excessive growth of the parathyroid gland, high levels of PTH, calcium and phosphorus, and HPT complications including bone disease and soft tissue and vascular calcification, which increases the risk for cardiovascular events.

The majority of an estimated 324,000 CKD patients on dialysis in Europe suffers from some degree of SHPT. According to the Dialysis Outcomes and Practice Patterns Study (DOPPS) 26 percent of CKD patients on dialysis throughout the world had PTH levels above the KDOQI guidelines (